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Evaluating the Clinical Effectiveness of a Community-based Hearing Aid Fitting Service Delivery Model Facilitated by Community Healthcare Workers (CHWs) Providing Smartphone-based In-situ and Pre-set Hearing Aid Fittings in Low- and Middle-income Communities (LMICs)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim: This study aims to establish the effectiveness of community-based hearing aid fittings facilitated by community healthcare workers (CHWs) using mobile health (mHealth) technologies in low- and middle-income communities (LMICs). The primary goal is to determine the efficacy of CHW-facilitated smartphone-based in-situ hearing aid (HA) fittings (a proprietary fitting based on the NAL-NL2 algorithm) and pre-set HAs fittings compared to minimal amplification through a single-blind randomized controlled trial (RCT). By comparing self-reported benefits between the experimental and control groups, this aim seeks to demonstrate the superiority of the CHW-facilitated smartphone-based and pre-set hearing aid fittings compared to minimal amplification.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years and older

• Confirmed mild to severe (20 to \< 80 dB PTA in both ears; (World Health Organization, 2021)) hearing loss (determined during baseline assessments)

• Willing/available to commit to at least 6- and 12-week follow-ups

Locations
Other Locations
South Africa
Khayelitsha Community
RECRUITING
Cape Town
Paarl Valley
RECRUITING
Paarl
Atteridgeville Community
RECRUITING
Pretoria
Contact Information
Primary
Caitlin Frisby, PhD Audiology
caitlin.frisby@up.ac.za
+27 78 300 2511
Backup
Tersia de Kock, MA (Audiology)
tersia@hearxfoundation.org
+27 84 514 2086
Time Frame
Start Date: 2025-05-21
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 90
Treatments
Experimental: In-situ Group
* The CHW will fit each participant in the in-situ group with the Lumens programmed using the smartphone-based in-situ (proprietary algorithm based on the NAL-NL2) fitting.~* Participants will select the listening environment they feel most comfortable with.
Other: Control Group
* Participants in the control group will be fitted with Lumens programmed using minimal gain (10 dB gain across frequencies regardless of degree of HL). This will be conducted by the CHW.~* Participants will select the listening environment they feel most comfortable with.
Experimental: Pre-set Group
● The CHW will fit each participant in the pre-set group with Go Ultra hearing aids on one of the four pre-set programs. Participants will select the program they feel most comfortable with.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Children's Hospital Medical Center, Cincinnati
Leads: University of Pretoria

This content was sourced from clinicaltrials.gov